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Biocon announces its supplemental BLA (sBLA) for biosimilar pegfilgrastim has been approved by the FDA. This additional approval relates to FDA approval of Biocon’s subsidiary Biocon Biologics’ new manufacturing facility in Bengalaru.

Shanghai Henlius announces proposed trastuzumab biosimilar met primary endpoint in Phase III clinical trials.

Coherus and Bioeq announce licensing agreement for Lucentis® (ranibizumab) in the US. Under the agreement, Bioeq will receive upfront and launch milestone payments, with both parties sharing the profits.

Pfizer receives Australian approval for bevacizumab biosimilar, Zirabev®.

FDA accepts BLA for proposed bevacizumab biosimilar.

Polpharma commences dosing in Phase III trials of proposed natalizumab biosimilar.

Sandoz launches pegfilgrastim product, Ziextenzo®, in the US, at a 37% discount to the reference product, Neulasta®.

FDA approves Pfizer’s adalimumab biosimilar Abrilada®. This product will not be launched until November 2023, under the terms of Pfizer’s agreement with AbbVie entered into in November 2018.

Sandoz releases results of Erelzi® studies, including interim results of the COMPACT study, and long-term cost savings modelling analysis.

Bio-Thera announces China’s National Medicinal Products Administration has approved its biosimilar adalimumab, Qletli® for the treatment of rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.